Suspended

C-TRACTCatheter-Directed Therapy for Chronic Venous Thrombosis Relief

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Study Aim

The main goal of this study is to evaluate how catheter-directed therapy combined with standard treatment affects post thrombotic syndrome severity in patients with chronic venous thrombosis and iliac vein obstruction.

What is being tested

Stents

Device
Who is being recruted

Cardiovascular Diseases+10

+ Leg Ulcer

+ Skin Diseases

Over 18 Years
+18 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: July 2018
See protocol details

Summary

Principal SponsorWashington University School of Medicine
Last updated: January 29, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 2, 2018

Actual date on which the first participant was enrolled.

This study focuses on finding better ways to treat a condition called Deep Iliac Obstruction-Post Thrombotic Syndrome (DIO-PTS), which severely affects people's lives. Current treatments don't work well for everyone, and some options are risky and costly. The study looks at a new method called Endovenous Therapy (EVT), which uses procedures like stent placement and ablation to improve blood flow in the veins. The goal is to see if this method can be safely used more often to relieve symptoms and improve quality of life for those with DIO-PTS. The study aims to provide clear answers on whether EVT should become a standard treatment practice or not. In the study, 250 participants with DIO-PTS are divided into two groups: one receiving EVT and the other continuing with standard treatment alone. EVT involves procedures such as inserting a small mesh tube to keep the vein open and using heat to close off problematic veins. All participants will receive the usual care for DIO-PTS as well. The effectiveness of the treatments will be evaluated by measuring changes in the severity of the symptoms after six months. Participants’ health and progress will be monitored for either 6 or 24 months, depending on when they joined the study. This will help determine whether EVT is a valuable addition to current treatment options.

Official TitleChronic Venous Thrombosis: Relief With Adjunctive Catheter-Directed Therapy - The C-TRACT Trial
NCT03250247
Principal SponsorWashington University School of Medicine
Last updated: January 29, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

225 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesLeg UlcerSkin DiseasesSkin UlcerThrombosisVaricose UlcerVaricose VeinsVascular DiseasesVenous InsufficiencyEmbolism and ThrombosisSkin and Connective Tissue DiseasesVenous ThrombosisPostthrombotic Syndrome

Criteria

2 inclusion criteria required to participate
Disabling (moderate-to-severe) PTS, defined by a) presence of chronic venous disease >= 3 months duration in a leg with history of DVT, as determined by the site principal investigator or a physician co-investigator; and b) substantial limitation of daily activities or work capacity due to venous symptoms or an open venous ulcer, per the same investigator.

Ipsilateral iliac vein obstruction documented within 12 months prior to consent by either: Occlusion or >50% or = 50% stenosis of the iliac vein on venogram, CT venogram, MR venogram, or intravascular ultrasound (IVUS); or Air plethysmography showing deep venous obstruction of the ipsilateral leg (reduced venous outflow fraction), and ultrasound showing echogenic material in the ipsilateral iliac vein and non-phasic continuous Doppler flow in the ipsilateral common femoral vein (CFV) in the presence of normal phasic Doppler flow in the contralateral CFV.

16 exclusion criteria prevent from participating
Chronic arterial limb ischemia (ankle-brachial index < 0.5 within the previous 1 month) in the ipsilateral leg (if peripheral arterial disease is present or suspected, an ankle-brachial index should be obtained and documented)

Presence of open venous ulcer > 50 cm2 area, suspicion for active ulcer infection, or visualization of bone or tendon within the ulcer in the ipsilateral leg

Hemoglobin < 8.0 g/dl, uncorrectable INR > 3.0, or platelet count < 75,000/ml

Severe renal impairment (on chronic dialysis or estimated GFR < 30 ml/min)

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Subjects randomized to EVT will receive the following: 1. imaging-guided iliac vein stent placement; 2. anticoagulant therapy for at least 6 months; 3. oral aspirin 81 mg for at least 6 months; and 4. optimal PTS therapy: medical, compression, lifestyle measures, and venous ulcer care

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 29 locations

Suspended

St. Joseph's Vascular Institute

Orange, United StatesOpen St. Joseph's Vascular Institute in Google Maps
Suspended

UCSF

San Francisco, United States
Suspended

Yale New Haven Hospital

New Haven, United States
Suspended

Christiana Care Hospital

Newark, United States
Suspended29 Study Centers